Label: KLEENEX ULTRA MOISTURIZING HAND SANITIZER- alcohol solution

  • NDC Code(s): 55118-530-10, 55118-530-11, 55118-530-12, 55118-530-88, view more
    55118-530-99
  • Packager: Kimberly-Clark Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 12, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Uses

    For personal hand hygiene to help prevent the spread of bacteria. Kills harmful bacteria or germs.

  • Warnings

    For external use only

    Flammability warning

    Keep away from open flame and sources of heat.

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a health care practitioner if irritation or redness develops or persists.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control centre immediately.

  • Directions

    Use enough foam to cover your hands. Rub hands together briskly until dry. Use as part of your daily cleansing routine.

  • Other information

    Report serious side effects from this product to 1-877-561-6587.

    Do not store above 110 °F (40 °C).

  • Inactive Ingredients

    Aloe Barbadensis Leaf Extract, Betaine, Camellia Sensis Leaf Extract, Citric Acid, Cucumis Sativus Fruit Extract (Cucumber), Glycerin, Isopropanol, Meadowfoam Amidopropyl Betaine, Panthenol, PEG-10 Dimethicone, Water/Eau/Aqua

  • Questions?

    1-888-346-4652

  • SPL UNCLASSIFIED SECTION

    Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076-2199

    Distributed in Canada by Kimberly-Clark Inc., Mississauga, Ontario L5B 3Y5.

  • PRINCIPAL DISPLAY PANEL - 1L Bottle Label

    34700

    Kleenex®
    BRAND MARQUE
    ULTRA

    Moisturizing Foam
    Hand Sanitizer

    SAME GREAT FORMULATION.
    Now Kleenex® Branded

    For Personal / Domestic Use Only

    1L (33.8 fl oz)

    Empty &
    Discard Pump
    PLASTIC
    BOTTLE

    how2recycle.info

    NPN 80030706

    ECOLOGO
    PRODUCT CERTIFIED FOR
    REDUCED ENVIRONMENTAL
    IMPACT. VIEW SPECIFIC
    ATTRIBUTES EVAUATED:
    UL.COM/EL UL 2784

    20-14-833-0-00

    PRINCIPAL DISPLAY PANEL - 1L Bottle Label
  • INGREDIENTS AND APPEARANCE
    KLEENEX ULTRA MOISTURIZING HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55118-530
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Betaine (UNII: 3SCV180C9W)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Panthenol (UNII: WV9CM0O67Z)  
    Glycerin (UNII: PDC6A3C0OX)  
    MEADOWFOAMAMIDOPROPYL BETAINE (UNII: HNV0L650LG)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Cucumber (UNII: YY7C30VXJT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55118-530-88236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2012
    2NDC:55118-530-99472 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2012
    3NDC:55118-530-1144 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2012
    4NDC:55118-530-101000 mL in 1 BAG; Type 0: Not a Combination Product03/01/2012
    5NDC:55118-530-121200 mL in 1 BAG; Type 0: Not a Combination Product03/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E03/01/2012
    Labeler - Kimberly-Clark Corporation (830997032)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tri-Pac Inc.020844956MANUFACTURE(55118-530) , LABEL(55118-530) , PACK(55118-530)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cyan Labs812754130MANUFACTURE(55118-530) , LABEL(55118-530) , ANALYSIS(55118-530) , PACK(55118-530)
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